FDA gives pediatric indication to device that detects traumatic brain hemorrhage

The FDA granted expanded indication to Infrascanner, a handheld device used for detecting traumatic supratentorial hematomas in adults, to now include pediatric patients aged 2 years and older.

“Infrascanner is now the only handheld device in the U.S. health care market cleared for use in the pediatric population to aid in the diagnosis of patients with a potential traumatic brain hemorrhage,” Baruch Ben Dor, PhD, president and CEO of InfraScan, the device’s manufacturer, said in a press release. “The Infrascanner is a cutting-edge technology that can now be used as an additional asset for clinicians as they follow the PECARN guidelines in their moderate risk pediatric patients’ evaluations.”

According to the release, research conducted at Children's Hospital of Philadelphia, Boston Children's Hospital, Colorado Children's Hospital, the Division of Global Neurosurgery and Neurology at Duke University, Baylor College of Medicine and Pittsburgh Children's Hospital led to this expanded indication.